Job Description

Senior Regulatory Affairs Analyst Venesco is seeking an experienced Senior Regulatory Affairs Analyst to support the Biomedical Advanced Research and Development Authority (BARDA), within the U.S. Department of Health and Human Services in Washington, DC. ***Contingent upon contract award*** Responsibilities Duties include, but not limited to:

• Support BARDA Program Office(s) as a subject matter expert in relevant field of experience(s) for vaccine, therapeutic, and/or antimicrobial advanced development; clinical and/or regulatory policy; and/or manufacturing capacity construction.
• Provide guidance documents and option papers on key issues related to the area(s) identified;
• Review contract proposal and related documents;
• Provide senior-level briefing(s) to ASPR/BARDA as required; Prepare regular reports to ASPR/BARDA management on various technical issues identified.
• Provide project development level portfolio management and oversight;
• Develop, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts;
• Provide subject matter expertise in regulatory affairs supporting MCM development pathways
• Strategize innovative regulatory approaches to MCM development against emerging threats
• Advise regulatory and BARDA senior leadership on critical programmatic and project level regulatory challenges
• Provide training and advisement to BARDA staff on regulations, authoring regulatory documents, and interactions with regulatory authorities
• Deliverables would include work products related to the development and management of regulatory affairs strategic planning and guidance within current and planned BARDA vaccine, therapeutic, device/diagnostic, and/or antimicrobial advanced development and acquisition contracts.

Minimum Required Qualifications:

• Citizenship: Must be a US citizen
• Clearance: Ability to obtain Public Trust
• Education: PhD in biology, chemistry, or pharmacy with commensurate experience.
• Years\xe2\x80\x99 experience: Minimum of 15 years of relevant industry experience at senior regulatory affairs positions in the pharmaceutical industry;

Additional Information:

• Location: Department of Health and Human Services
• 200 Independence Ave,SW Washington, DC 20201 United States
• Travel: 10% Remote, Onsite, or Hybrid: Onsite; telework eligible

Job Type: Full-time Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Education:

• Doctorate (Preferred)

Experience:

• vaccine, therapeutic, and/or antimicrobial development: 10 years (Preferred)
• regulatory affairs strategic planning and guidance: 10 years (Preferred)
• senior-level briefing: 10 years (Preferred)
• project development level portfolio management: 10 years (Preferred)

Work Location: Hybrid remote in Washington, DC 20201

• Health insurance